BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS ULTRA TIGHT

    MDR report key: 23390853 · Received October 27, 2025

    Report

    Report Number
    1413787-2025-00240
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 27, 2025
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    EFW
    UDI-DI
    00070942002431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CUSTOMER USED IDB AND IT BROKE OFF IN BETWEEN HER TEETH. ALTHOUGH THERE WAS NO DAMAGE TO PERMANENT STRUCTURE, CUSTOMER DID VISIT TO URGENT CARE TO REMOVE BROKEN PIECE OF IDB. HER JAW IS SORE FROM HAVING HER JAW OPEN FOR A LONG AMOUNT OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428822 GUM® PROXABRUSH® GO-BETWEENS®; CLEANERS ULTRA TIGHT INTERDENTAL BRUSH EFW SUNSTAR AMERICAS, INC. 871RQ 00070942002431

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention